Mechanisms of Desensitization During Peanut Oral Immunotherapy

Food Hypersensitivity Clinical Trial

— PnOIT4  

Official title:

Mechanisms of Desensitization During Peanut Oral Immunotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814241
• Other study ID #: 13-0900
• Secondary ID: R01AI068074
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2013
• Last updated: February 27, 2018
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.

Description:

Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age 4 to up to 12 years of age of any gender, race, or ethnicity.

• Minimum weight 16 kg at the time of enrollment.

• Physician diagnosis of peanut allergy OR convincing clinical history of an allergic reaction to peanut.

• Detectable serum peanut -specific IgE level (CAP-FEIA = 0.35 kU/L) and a positive SPT (wheal = 3mm on skin prick test to peanut extract compared to a negative control.)

• Allergic reaction to = 1 gm peanut protein during a blinded oral challenge test conducted at screening (e.g., a double-blinded, placebo-controlled food challenge [DBPCFC]).

• Written informed consent from parent/guardian.

• Written assent from subject if applicable

• Consumption of oat-containing product within 90 days prior to enrollment

Exclusion Criteria:

• History of allergic reaction to peanut consistent with severe anaphylaxis (defined as hypotension/shock; or neurologic impairment).

• Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes.

• Active eosinophilic gastrointestinal disease in the past 2 years

• Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1

• Inhalant allergen immunotherapy that has not yet reached maintenance dosing.

• Asthma defined as moderate or severe persistent by National Asthma Education and Prevention Program Expert Panel Guidelines (e.g. asthma that requires more than fluticasone 440 mcg or its equivalent daily for adequate control).

• Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation.

• Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1.

• Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, Systemic corticosteroid therapy of up to a total of three weeks is allowed.

• Use of investigational drug in 90 days prior to visit -1.

• Plan to use any investigational drug during the study period.

• The presence of any medical condition that the investigator deems incompatible with participation in the trial.

• Inability to speak English.

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Open label peanut OIT
Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut	Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.	44 weeks
Other	Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge	The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)	44 weeks
Other	Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge	The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut	44 weeks
Primary	Percentage of Subjects Who Develop Desensitization	The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.	40 weeks
Secondary	Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped	The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.	4 weeks